Trials / Completed
CompletedNCT03337542
AR101 Real-World Open-Label Extension Study
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 243 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
Detailed description
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR101 | AR101 |
Timeline
- Start date
- 2017-10-18
- Primary completion
- 2019-09-20
- Completion
- 2019-09-20
- First posted
- 2017-11-09
- Last updated
- 2021-11-02
- Results posted
- 2021-11-02
Locations
60 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03337542. Inclusion in this directory is not an endorsement.